Pharmaceutical giant AstraZeneca says it has held no discussions with the U.S. government about emergency authorization for the COVID-19 vaccine it is manufacturing.
That vaccine is still undergoing late stage human clinical trials in several sites around the world, including in the U.K. and the U.S., making a rapid approval under the criteria the U.S. Food and Drug Administration has established so far a long shot.
British newspaper The Financial Times reported Sunday that the Trump Administration was considering a plan to fast-track approval of the vaccine, which has been developed by researchers at Oxford University in the U.K. and which AstraZeneca has agreed to help test and manufacture.
The paper cited three anonymous sources that it said had been briefed on the White House plan which, it said, included an option for the FDA to grant “emergency use authorization” to AstraZeneca’s vaccine if the results are positive from a late stage clinical trial in the U.K. that Oxford is running. That study involves about 10,000 people, and is expected to announce results as early as next month.
The FDA has previously said that any vaccine seeking a license will need to show positive results in a much larger clinical trial, involving at least 30,000 people. AstraZeneca is starting a clinical trial of that size in the U.S. for the vaccine, but results are not expected to be ready until later in the autumn.
President Donald Trump is reportedly desperate to have a COVID-19 vaccine approved before the November 3rd presidential election in order to boost his chances of reelection. Some are even speculating he sees it as his “October surprise.” Trump is currently trailing Democratic presidential nominee Joe Biden by about 10 points in national opinion polls.
“AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” AstraZeneca said in a statement Monday in response to The FT story. “Late stage Phase II/III trials for [the Oxford vaccine candidate] are ongoing in the U.K. and other markets globally, and we do not anticipate efficacy results until later this year.”
Despite the denial, investors sent AstraZeneca shares up 3.7% in morning trade on Monday.
“Vaccines you’ll be hearing about very soon”
The FT report came on the same day that Trump held a press conference to announce the FDA had granted emergency use authorization for blood plasma from recovered COVID-19 patients to be used to treat those currently suffering from the disease.
At that press conference, Trump hinted that a vaccine authorization might be imminent. “We’re years ahead of approvals than we would be if we went by the speed levels of past administrations. We would be two years, three years behind,” the President said. “That includes vaccines that you’ll be hearing about very soon.”
Leading Democrats have said the White House must not approve a vaccine before reliable safety and efficacy results are available. In addition, Peter Marks, who heads the FDA division responsible for assessing vaccine candidates, told Reuters he would resign if the Trump Administration pressures the agency to approve a vaccine without adequate trial data showing it was safe and effective.
In addition to the Oxford-AstraZeneca vaccine, several other vaccines, including ones being developed by biotech company Moderna and pharmaceutical giant Pfizer, are also now undergoing large, 30,000-person Phase III clinical trials in the U.S.
Moderna began recruiting volunteers in July and has said it will complete enrollment by the end of September. Pfizer says it has recruited just over a third of its participants and will be “ready for regulatory review in October.” But even so, it is unclear that a vaccine could be approved under the FDA’s existing guidelines before November 3.
On Saturday, an impatient Trump alleged in a Tweet that unnamed individuals within the FDA were deliberately trying to slow enrollment in vaccine trials so that clinical trial results would not be available until after the election. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump wrote. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
That tweet drew condemnation from U.S. Speaker of the House Nancy Pelosi, who called Trump’s tweet “a dangerous statement” that “went beyond the pale” and could “jeopardize the health and wellbeing of the American people.”
